# K091412: Clean Peak Flow Meter

- Pathway: 510(k) (Special)
- Applicant: Viasys Healthcare GmbH
- Decided: Aug 21, 2009 after 100 days
- Product code: BZH (Meter, Peak Flow, Spirometry)
- Device class: 2
- Regulation: 21 CFR 868.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K781922 (1979). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030586: Micropeak, Micro Direct, Inc. (2003) Summary page 2.

## Indications for use
The Clean Peak Flow Meter simply measures a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma. Targeted population: Children scale / 50 - 380 liters/minutes Patients requiring the measurement of peak expiratory flow rate from 6 years on up to 12 years. Adult scale / 50 - 800 liters/minutes Patients requiring the measurement of peak expiratory flow rate from 6 years on. Environment of use: Places where a patient may require the measurement of their peak expriatory flow rate.

Source page: https://510kreport.com/device/K091412
Methodology: https://510kreport.com/methodology